The Board of Management of 4SC AG (4SC, FSE Prime Standard: VSC) announced today that according to its best judgment, the Company has now incurred a cumulative loss amounting to more than half of its share capital based on the […]
Author: Firma 4SC
4SC provides Q3 highlights and financial forecast
Posted on Posted in General
4SC AG (4SC or "the Company") (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), today provided a business update for the three months ended 30 September 2023, as […]
4SC receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL in the European Union
Posted on Posted in Research / Development
The European Medicines Agency (EMA) has granted Orphan Drug Designation for resminostat for treatment of cutaneous T-cell lymphoma (CTCL) ODD benefits include 10 years’ market exclusivity in the European Union The Marketing Authorisation Application (MAA) for Kinselby (resminostat) in […]
4SC AG: 4SC provides Q2 2023 and H1 2023 update
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Positive topline data for resminostat in RESMAIN pivotal study demonstrating 97.6% improvement in progression free survival in CTCL patients and risk reduction of 38% compared to placebo Marketing Authorization Application for resminostat and nominated trade name of Kinselby accepted by […]
4SC AG: RESMAIN Study Results to be Presented at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 23 September 2023
Posted on Posted in Research / Development
4SC AG (4SC, FSE Prime Standard: VSC) announced that the results from the RESMAIN Study evaluating resminostat (Kinselby) in maintenance treatment of patients with advanced cutaneous T-cell lymphoma (CTCL) will be presented by Professor Dr. Rudolf Stadler at the EORTC […]
4SC AG – Resminostat Marketing Application Proceeding & Kinselby accepted as Tradename
Posted on Posted in Research / Development
. The European Medicines Agency (EMA) has notified 4SC that it has accepted its Letter of Intent to Submit a Marketing Authorization Application (MAA) and rapporteurs are expected to be appointed in July 2023 EMA has notified 4SC that its […]
Resminostat: 4SC Filed Letter of Intent to the European Medicines Agency (EMA)
Posted on Posted in Research / Development
4SC AG (4SC, FSE Prime Standard: VSC) has now filed with EMA its letter of intent to file for Marketing Authorization for resminostat in cutaneous T cell lymphoma (CTCL) and request the appointment of rapporteurs. Given the clear benefit provided […]
4SC AG – RESMAIN Trial Meets Primary Endpoint in Cutaneous T-Cell Lymphoma (CTCL)
Posted on Posted in Research / Development
Resminostat met the primary endpoint in the RESMAIN study, demonstrating a statistically significant improvement in progression free survival in CTCL patients by ninety seven point six percent (97.6%) with a risk reduction of thirty eight percent (38%) compared to placebo […]
4SC AG:4SC provides Q1 2023 update
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4SC AG (4SC, FSE Prime Standard: VSC) today published the Q1 Announcement 2023, presenting all material developments up to 31 March 2023 and the Company’s current outlook. The full communication is available for download on 4SC’s website. Jason Loveridge, Ph.D., […]
4SC AG:4SC AG provides results for financial year 2022 and outlook for 2023
Posted on Posted in General
4SC AG (4SC, FSE Prime Standard: VSC) today published the financial results for the financial year ended 31 December 2022, presenting all material reporting period developments and provides an outlook for 2023. The full report is available at 4SC’s website. […]